Intra Incisional Infiltration of Bupivacaine Versus Meloxicam on Post Cesarean Section Pain Relief
Study Details
Study Description
Brief Summary
Investigation: compare the effect of local infiltration of incision site with bupivacaine and local infiltration with meloxicam in women undergoing cesarean sections on postoperative pain relief and analgesic requirement.
Condition: post cesarean sections analgesia intervention: infiltration of incision bupivacaine versus meloxicam Phase: Not applicable
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Detailed Description
study type: randomized clinical trial actual enrollment: 119 allocation: Random intervention model: three groups assignment masking: open lebal primary purpose: pain relief after Cesarean section actual study start: March 3, 2019 Primary Completion: March 5, 2020 actual study completion date: May 9, 2020
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: bupivacaine group included 35 patients in which and subcutaneous tissue (upper and lower flaps) were infiltrated with 20 ml of 0.25% bupivacaine hydrochloride. (Marcaine, 25% vial, Astra Zeneca) diluted in 20 ml of 0.9% saline. |
Drug: local ifiltration Bupivacaine, Meloxican and placebo
no other intervention done
|
Active Comparator: meloxicam group included 35 patients in which and subcutaneous tissue (upper and lower flaps) were infiltrated with meloxicam 15mg (Anticox 2 ampoule 15mg/3ml, ADWIA Pharmaceuticals). diluted in 20 ml of 0.9% saline. |
Drug: local ifiltration Bupivacaine, Meloxican and placebo
no other intervention done
|
Active Comparator: placebo group included 35 patients in which skin and subcutaneous tissue was infiltrated with 20 ml 0.9% saline. |
Drug: local ifiltration Bupivacaine, Meloxican and placebo
no other intervention done
|
Outcome Measures
Primary Outcome Measures
- Postoperative pain scores [immediately after the intervention]
Assessment of pain scores after Cesarean section
- Postoperative analgesic requirements [immediately after the intervention]
Assessment of Postoperative analgesic requirements
- time of first dose of analgesia [immediately after the intervention]
Determination of time of first dose of analgesia
Secondary Outcome Measures
- Postoperative fever [immediately after the intervention]
Assessment of Postoperative fever
- onset of mobilization [immediately after the intervention]
Assessment of onset of mobilization
- side effects of medications [immediately after the intervention]
Assessment of side effects of medications
- Pain assessment by visual analogue scale [immediately after the intervention]
Post-operative pain assessment was done using a 10-point visual analogue scale
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age between 21-40 years
-
Elective C.S at term
-
Patient having no medical disorders
-
Patient with no obstetrical complications
Exclusion Criteria:
-
extreme of reproductive age
-
allergy to local anesthetic infiltration agent
-
any medical disorders or obstetrical complications as ante partum hemorrhag, pre-eclampsia
-
refusal to participate in the trial.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Menoufia University hospital | Shibīn Al Kawm | Menoufia | Egypt | 11111 |
Sponsors and Collaborators
- Menoufia University
Investigators
- Principal Investigator: Mohamed E Anter, MD, Menoufia University hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 12/2019OBSGN38